None listed
Conditions
Brief summary
Cocoa flavanols have been associated with several health benefits including cardiovascular and cognitive functions. Cocoa flavanols increase the formation of endothelial nitric oxide, responsible for the increased blood flow and improved cardiovascular and vascular function. A small number of studies have tested the acute effect of cocoa on cognitive function, demonstrating benefits on alertness, fatigue, and mood using a cognitively demanding test in a population of young students. While early studies used high-flavanol cocoa powder compared with low-flavanol powder as control, a truly double-blind design using cocoa versus non-flavanol containing placebo tablets have been tested in a previous study undertaken by this team, eliminating potential confounding of low-dose flavanol products. While the team's previous study tested a population of young students (mean age = 23 years), the proposed project aims to explore an older population (mean age = 60 years) using the Swinburne University Computerised Cognitive Assessment Battery (SUCCAB) test, assessing speed and accuracy, which has been shown to correlate to cognitive decline through ageing. the study will test the hypothesis whether an acute dose of cocoa improves cognitive function in a middle aged population.
Interventions
This randomised double-blind placebo-controlled trial will test the acute effect and dose-response of 2 doses of cocoa (Dose 1: 2 tablets: 6116 mg Theobroma cacao seed extract standardised to 500 mg catechins polyphenols and 11.12 mg theobromine; Dose 2: 4 tablets containing 1g of catechins polyphenols and 22.24 mg theobromine) compared to flavanols-free placebo on cognition using the computerised SUCCAB test battery in a middle aged population in the NIIM cognitive function lab. On Day 1, afte
This randomised double-blind placebo-controlled trial will test the acute effect and dose-response of 2 doses of cocoa (Dose 1: 2 tablets: 6116 mg Theobroma cacao seed extract standardised to 500 mg catechins polyphenols and 11.12 mg theobromine; Dose 2: 4 tablets containing 1g of catechins polyphenols and 22.24 mg theobromine) compared to flavanols-free placebo on cognition using the computerised SUCCAB test battery in a middle aged population in the NIIM cognitive function lab. On Day 1, after baseline assessment cocoa or placebo tablets will be given to participants, and cognition will be tested on 2 hours after ingestion of the trial tablets. Cognitive assessment will be repeated 4 weeks later on the same participants using a different dose of cocoa.
Sponsors
National Institute of Integrative Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
- Adults 40-70 years - Have a good working knowledge of English
Exclusion criteria
- Colour blind - Currently suffering from medically diagnosed cardiovascular or cognitive impairment, psychiatric or neurological conditions - Taking any cognitive enhancing medications or herbal supplements or illicit drugs - Taking antidepressants, antipsychotics or anxiolytics - Taking anti-coagulants or have bleeding disorders - Pregnant or lactating - Participating in any other study
Outcome results
None listed